Add missing "must support" data elements to support the MU2015 and CCDS requirements: (A) Device Identifier; and (B) The following identifiers that compose the Production Identifier: (1) The lot or batch within which a device was manufactured; (2) The ser

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Medium
    • US Core (FHIR)
    • STU3
    • Structured Documents
    • Device [deprecated]
    • Profiles and Extensions
    • SD
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      Update Device.udiCarrier.carrierHRF and Device.*udiCarrier.carrierAIDC *to Must Support

      Fix introductory text to match (i.e. a UDI string ("udicarrier") to Device.udiCarrier.carrierHRF)

      Item was reopened on 4/18/2019

      Previous vote on original disposition: Eric Haas/Ioana Singureanu: 22-0-0

      Motion: Marti Velezis/Hans

      Relax the cardinality Device.udiCarrier to 0..1 to accomodate for devices that do not have UDI information (e.g. historical data or patient reported data). Add rationale to the description&constraint udiCarrier.

      Opposed: 0, Abstain: 5, In favor: 53

      2nd Motion: Marti/Calvin

      Opposed: 0, Abstain: 5, In favor: 50

      Add must support flags to UDI elements as proposed below, to include the parsed elements and make them available for the Fall 2019 STU Update.

      Modified to handle self-reported medical device use or implant as requested by the Argonaut community and is inline with the other HL7 respresentations of device identification information.

      + device.udiCarrier "S" [0..1] is required for recording an implant of a medical device (excludes self-reported implants that do not include UDI information) [Note: made in previous motion]

      ++ Device.udiCarrier.carrierHRF OR Device.udiCarrier.carrierAIDC "S" [0..1] SHOULD be supported. One is required when the udiCarrier is provided. [Note: This is still a topic of discussion and testing, and may be subject to further refinement.]

      ++ Device.udiCarrier.deviceIdentifier - "S", [1..1] is required when the udiCarrier is provided

      At least one or more Production identifiers must be provided. When a production identifier is provided in the UDI (udiCarrier) then it must also be parsed and exchanged as one of the following device elements:

      + Device.distinctIdentifier "S" [0..1] SHOULD be supported for HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c).

      + Device.manufactureDate "S", [0..1] SHOULD be supported when the UDI (udiCarrier) specifies a manufactureDate

      + Device.expirationDate "S", [0..1] SHOULD be supported when the UDI (udiCarrier) specifies an expirationDate

      + Device.lotNumber "S". [0..1] SHOULD be supported when the UDI (udiCarrier) specifies a lot number

      + Device.serialNumber "S", [0..1] SHOULD be supported when the UDI (udiCarrier) specifies a serial number

      Show
      Update Device. udiCarrier.carrierHRF and Device.*udiCarrier.carrierAIDC *to Must Support Fix introductory text to match (i.e. a UDI string ("udicarrier") to Device. udiCarrier.carrierHRF) Item was reopened on 4/18/2019 Previous vote on original disposition: Eric Haas/Ioana Singureanu: 22-0-0 Motion: Marti Velezis/Hans Relax the cardinality Device.udiCarrier to 0..1 to accomodate for devices that do not have UDI information (e.g. historical data or patient reported data). Add rationale to the description&constraint udiCarrier. Opposed: 0, Abstain: 5, In favor: 53 2nd Motion: Marti/Calvin Opposed: 0, Abstain: 5, In favor: 50 Add must support flags to UDI elements as proposed below, to include the parsed elements and make them available for the Fall 2019 STU Update. Modified to handle self-reported medical device use or implant as requested by the Argonaut community and is inline with the other HL7 respresentations of device identification information. + device.udiCarrier "S" [0..1] is required for recording an implant of a medical device (excludes self-reported implants that do not include UDI information) [Note: made in previous motion] ++ Device.udiCarrier.carrierHRF OR Device.udiCarrier.carrierAIDC "S" [0..1] SHOULD be supported. One is required when the udiCarrier is provided. [Note: This is still a topic of discussion and testing, and may be subject to further refinement.] ++ Device.udiCarrier.deviceIdentifier - "S", [1..1] is required when the udiCarrier is provided At least one or more Production identifiers must be provided. When a production identifier is provided in the UDI (udiCarrier) then it must also be parsed and exchanged as one of the following device elements: + Device.distinctIdentifier "S" [0..1] SHOULD be supported for HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c). + Device.manufactureDate "S", [0..1] SHOULD be supported when the UDI (udiCarrier) specifies a manufactureDate + Device.expirationDate "S", [0..1] SHOULD be supported when the UDI (udiCarrier) specifies an expirationDate + Device.lotNumber "S". [0..1] SHOULD be supported when the UDI (udiCarrier) specifies a lot number + Device.serialNumber "S", [0..1] SHOULD be supported when the UDI (udiCarrier) specifies a serial number
    • Ioana Singureanu/Hans Buitendijk: 48-0-5
    • Enhancement
    • Compatible, substantive

      Comment:

      The following us-core-device "must support" data elements are missing:

      + Device.udiCarrier: "S", [1..1] for implantable devices

      + Device.udiCarrrier.deviceIdentifier - is mandatory, therefore the parent element has to be mandatory and it requires "S", [1..1]

      + Device.udiCarrier.HRFcarrier OR Device.udiCarrier.AIDCcarrier MAY be supported

      + Device.distictIdentifier "S" [0..1] SHALL be supported for HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c).

      + Device.manufactureDate "S", [1..1]

      + Device.expirationDate "S", [1..1]

      + Device.lotNumber "S". [0..1] - SHALL be supported if the Production Identifier specifies a lot number

      + Device.serialNumber "S", [0..1] - SHALL be supported if the Production Identifier specifies a serial number

      Summary:

      Add missing "must support" data elements to support the MU2015 and CCDS requirements: (A) Device Identifier; and (B) The following identifiers that compose the Production Identifier: (1) The lot or batch within which a device was manufactured; (2) The serial number of a specific device; (3) The expiration date of a specific device; (4) The date a specific device was manufactured; and (5) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c)."

        1. UDI GForge Tracker 20029 Response to Hans_FINAL.docx
          178 kB

            Assignee:
            Unassigned
            Reporter:
            Ioana Singureanu
            Ioana Singureanu
            Watchers:
            3 Start watching this issue

              Created:
              Updated:
              Resolved: